Recon: FDA says Lilly’s tirzepatide shortage is resolved; Merck’s HIV therapy achieves success in pair of Phase 3 trials

• FDA confirms shortage of weight loss drug tirzepatide is over, gives compounders a grace period (STAT)
• Muscle dysmorphia in boys and men is on the rise, fueled by social media (STAT)
• What biotech could bring in 2025 (STAT)
• Copy-pasted notes and untrained providers: First federal audit of autism therapy finds problems in every record (STAT)
• The health care deal is in jeopardy (STAT)
• US FDA declines to approve Zealand Pharma's bowel disease drug (Reuters)
• Merck's HIV treatment meets main goal in two late-stage studies (Reuters)
• ‘Research that’s desperately needed’: White House conference spotlights women’s health (MedTech Dive)
• Rare, Pediatric Drug Development and Reimbursement Boosted In Shaky US Spending Deal (Pink Sheet)
• Kennedy ticks off easy wins in US Senate tour, tougher meetings on top health job ahead (Reuters)  

• Eli Lilly's Alzheimer's treatment approved in China (Reuters)
• The DRC ‘mystery illness’ shows why the U.S. can’t ‘pause’ infectious disease work (STAT)
• Lonza expands capsule footprint; BioCentriq's new HQ (Endpoints)
• German Medtechs Urge Incoming Government To Be More Collaborative (MedTech Insight)
• Alexion Cautions Against Reduction In EU Orphan Drug Incentives (Pink Sheet)

• After two rejections, FDA approves Mesoblast's first-of-its-kind cell therapy (Fierce Pharma)
• Biotech stocks hammered after Fed rate projections (STAT)
• Vertex touts pain drug results, but medicine does not outperform placebo in sciatica study (STAT)
• The Endpoints 2024 winners and losers list: Who was up and who was down in biopharma (Endpoints)
• Exclusive: Can oral antibodies work? A small startup thinks it has an answer (Endpoints)
• Updated: Flagship gene therapy startup Ring Therapeutics nearly halves workforce as CEO departs (Endpoints)
• What health tech startups can expect in 2025 (Endpoints)
• Gilead deepens its stake in Assembly Biosciences; NGM licenses out MASH drug (Endpoints)
• Novartis says 330 jobs hit as it closes MorphoSys sites (Reuters)
• Medline sets stage for blockbuster US IPO with confidential filing (Reuters)
• Playing catch-up with Pfizer and Roche, China-made ALK drug clears FDA in lung cancer (Fierce Pharma)
• Klick Health goes on a hiring spree to close out the year, adding 22 new leaders (Fierce Pharma)
• Analysts tip BMS’ Cobenfy to be top dog in growing schizophrenia market (Fierce Pharma)
• Gene Therapy Follow-Up: Balance Data Needs And Patient Burden, Bluebird Bio Exec Says (Pink Sheet)

• These challenges could delay brain-computer interfaces from becoming a reality for patients (STAT)
• Boston Scientific updates cryoablation catheter instructions after 4 death reports (MedTech Dive)
• Medical device recalls under the spotlight in 2024 (MedTech Dive)
• Dexcom Participates In ŌURA $200M Series D Funding Round (MedTech Insight)

• Feds accuse CVS of filling ‘thousands’ of illicit opioid prescriptions (STAT)
• Health plan formularies lowered barriers to fair access to some drugs, analysis finds (STAT)
• 2025 forecast: The government crackdown on pharmas' direct-to-consumer outreach marches on (Fierce Pharma)
• Pharma's reputation is stable-ish. Will that survive Trump 2.0? (Fierce Pharma)
• Chink In PBM Armor? ‘Delinking’ Policy In Spending Bill But Passage Unclear (Pink Sheet)